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Optimizing the Floreciendo Sexual and Reproductive Health Workshop for Latina Teens and Female Caregivers: A Pilot

Recruiting
14 years of age
Both
Phase N/A

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Overview

Floreciendo is a sexual and reproductive health workshop for Latina teens (ages 14-18 years) and their female caregivers (e.g., mothers, sisters, grandmothers). This study involves conducting a pilot optimization trial of Floreciendo using the multiphase optimization strategy (MOST) framework. The feasibility of using a 2 x 2 x 2 factorial trial design and the acceptability and preliminary effectiveness of the intervention components of Floreciendo will be examined. This work will be conducted in partnership with community-based organizations in the Chicagoland area.

Description

In the U.S., Latina teens face a disproportionate burden of HIV/AIDS/sexually-transmitted infections (STIs) and other adverse consequences of risky sexual behavior. Parents play a key role in shaping the sexual behavior of their teens as they transition into adulthood. Positive parenting practices-including monitoring, open parent-child communication, and parent-child bonding-have been shown to deter teens' engagement in high-risk behavior. Interventions which engage parents have shown positive effects on youths' sexual health, including among Latinos. Effective Latina mother-daughter sexual health programs are critically needed since Latina mothers are less likely to discuss sexual risk behaviors with their teens than White or Black mothers but are greatly respected as figures of authority in Latino tradition.

This study centers on Floreciendo, a sexual and reproductive health workshop for Latina teens and their female caregivers which was adapted from the evidence-based IMARA (Informed, Motivated, Aware, and Responsible Adolescents and Adults) intervention. Floreciendo is comprised of 4 two-hour sessions, during which teens and caregivers complete separate and joint activities. This study will draw on the multiphase optimization strategy (MOST) framework, an engineering-inspired methodological framework for optimizing an intervention by identifying an intervention package that produces the best expected outcome achievable within key constraints.

The goal of the study is to carry out a pilot optimization trial of Floreciendo using the MOST framework. In partnership with community-based organizations in the Chicagoland area, approximately 92 teen-caregiver dyads (184 participants) will be enrolled. All participants will receive the first workshop session (the constant). In a 2 x 2 x 2 factorial design, small groups of teen-caregiver dyads will be randomized to receive different combinations of the remaining three workshop sessions (the intervention components): 1) condoms & contraception; 2) family strengthening, and 3) gender and relationships. Primary outcomes are: 1) feasibility of using a factorial trial design, 2) acceptability of the intervention components, and 3) preliminary effectiveness of the intervention components on sexual risk behavior. Secondary outcomes are preliminary effectiveness of the intervention components on incidence of STIs (a biological measure of chlamydia, gonorrhea, and trichomonas) and unplanned pregnancy (self-reported) at 6 months. Primary and secondary effectiveness outcomes will be assessed among teens.

Eligibility

Inclusion criteria for teens:

  1. Identify as Latina
  2. Be 14-18 years old
  3. Speak English and/or Spanish
  4. Be available to participate in the workshop and research activities in person at one of the community partner organizations
  5. Have a female caregiver who is available to participate in the workshop and research activities in person at one of the community partner organizations
  6. Be living with or in daily contact with the female caregiver.

Inclusion criteria for female caregivers:

  1. Be the mother or a female caregiver (e.g., aunt, sister, grandmother) of a Latina teen (aged 14-18 years old)
  2. Be 19 years old or older
  3. Speak English and/or Spanish
  4. Be available to participate in the workshop and research activities in person at one of the community partner organizations
  5. Be invited by a Latina teen (14-18 years old) who is available to participate in the workshop and research activities in person at one of the community partner organizations
  6. Be living with or in daily contact with the Latina teen.
        Latina teens and female caregivers must agree to participate as a dyad, and teens' refusal
        will supersede parental consent.
        Exclusion Criteria:
        Teens and caregivers will be excluded if they are unable to understand the consent/assent
        process and provide informed consent/assent. Teens may or may not be sexually active; this
        will not be an exclusion criterium. Information about teens' sexual activity will not be
        shared with caregivers to reduce consent/assent barriers. If there is more than one
        eligible adolescent in the family, we will randomly select one to maintain independent
        observations. Teens or caregivers who become pregnant during the study may continue to
        participate. Prisoners will be excluded.

Study details

Sexual Risk Behavior, Sexually Transmitted Infections, Unplanned Pregnancy

NCT06223165

University of Illinois at Chicago

17 May 2024

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